Proactive Therapeutic Drug Monitoring Based Adalimumab Therapy Optimization in Patients With Rheumatoid Arthritis (TDM-RA)

Boston Medical Center (BMC)

Status: Terminated

Conditions: Rheumatoid Arthritis

Treatments: Other: Therapeutic drug monitoring (TDM)

Study type: Interventional

Funder types: Other

Identifiers

NCT05460390

H-42873

Details and patient eligibility

About

Current standard of care of rheumatoid arthritis (RA) management includes a routine clinical assessment of disease activity to adjust therapy. For the most part, therapy adjustment for therapy non-response and/or suboptimal therapy response leads to therapy switch within the same class of therapy or to a different class of therapy. The lack of objective data to titrate dose of a given therapeutic agent for maximal possible efficacy makes it difficult for providers and payors to titrate dose as needed.

Therapeutic drug monitoring (TDM) provides objective data for a proactive and individualized therapy optimization based on serum drug levels and the presence or absence of anti-drug antibodies. Maintaining optimal trough drug concentration is a proven concept of therapeutics. With respect to adalimumab, this approach helps to maximize therapeutic efficacy and prevent anti-adalimumab antibody development. However, lack of drug and disease state specific published data creates a barrier for a wider adoption of TDM into clinical practice.

The objective of this single site, open label, randomized, parallel group pilot study is to investigate whether proactive therapeutic drug monitoring based adalimumab dose optimization results in higher rate of achieving and/or maintaining therapeutic goal compared to standard of care in patients with rheumatoid arthritis.

Enrollment: 5 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Diagnosis of rheumatoid arthritis
• Starting or already being treated with standard dose adalimumab, 40 mg subcutaneously (SQ) every two weeks
• Good medication adherence rate defined as Proportion of Days Covered (PDC) 80% and above

Exclusion criteria

• Detectable anti-adalimumab antibodies
• Overlapping immune mediated diseases
• Steroid therapy for more than 2 months prior to study enrollment
• Poor medication adherence rate (PDC < 80%)
• History of recurrent infection resulting in therapy pause
• Pregnant or lactating

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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5 participants in 2 patient groups

TDM based adalimumab dose optimization group

Experimental group

Description:

Therapeutic drug monitoring (TDM) provides an opportunity for a proactive and individualized therapy optimization based on serum drug concentration and anti-drug antibodies development.

Treatment:

Other: Therapeutic drug monitoring (TDM)

Standard of care

No Intervention group

Description:

Standard of care practice for RA management is based on disease activity guided therapy adjustments.